There is no evidence from randomised controlled trials demonstrating that the benefits of danazol outweigh its risks in treating uterine fibroids. Danazol is a synthetic isoxazole derivative chemically related to 17-ethinyl testosterone which creates a high androgen and low estrogen environment, resulting in the wasting of endometrium and shrinkage of fibroids. Despite its benefits, various undesirable side effects have also been reported. These include acne, hirsutism (excess hair in females, with an adult male pattern of distribution), weight gain, irritability, musculoskeletal pain, hot flushes, and breast atrophy, which many women may not tolerate. The review found no evidence demonstrating that the benefits of danazol outweigh the risks in treating uterine fibroids.
Read the full abstract
Uterine fibroids (myomas, fibromyomas, leiomyomas) are the most common benign tumours of the female genital tract. Danazol, a synthetic isoxazole derivative chemically related to 17-ethinyl testosterone, has been used for many years for the treatment of women with uterine fibroids.This is an update of the review published in 2009.
Objectives
To evaluate the effectiveness and safety of danazol in women with uterine fibroids.
Search strategy
We searched the Cochrane Menstrual Disorders and Subfertility Review Group Specialised Register; Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 4); MEDLINE; EMBASE; Chinese Biomedical Disc; and the China National Knowledge Infrastructure for relevant trials (to December 2010). Attempts were made to identify trials from references in published studies. We also searched for ongoing trials in the five major clinical trials registries.
Selection criteria
Randomised controlled trials of danazol versus placebo or any other medical therapy in women with uterine fibroids confirmed by medical procedures, regardless of the women's symptoms or age. Studies of women with malignancies were excluded.
Data collection and analysis
Data extraction and risk of bias assessment were not performed because there were no identified studies.
Main results
We did not identify any studies which met our full inclusion criteria.
Authors' conclusions
There is no reliable evidence available from randomised controlled trials regarding the benefits or harms of the use of danazol for treating uterine fibroids.
